Raw Materials Risk Management in GMP Facilities

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This training program will provide regulatory requirements (US) of 21 CFR 111 for Dietary Supplements, 210/211 for Drugs,  820 for Medical Devices, and 4 for Combination Products,  and will illustrate the key issues with examples. It will furnish details on what raw materials management from specification, purchasing, receipt, QC, storage, manufacturing, finished goods, and final QA quality  management systems are mandated to address.

Why Should You Attend?

The control of raw materials (RM), as well as components and sub-assemblies is an important element of the CGMPs for all regulated industries.  This includes acceptable materials and non-conforming materials, their separation, disposition, resolution and handling. Manufacturers are required to manage carefully their entire supply chain, internally as well as externally. The FDA focuses on how companies are addressing such systems and procedures and their functional implementation.

This subject touches on most of the basic CGMP concerns and requirements for industries as raw material is followed from design control call out and selection, to specification generation, sourcing and purchasing, receipt and initial QC inspection, routing / handling, storage, issuance, consumption in the manufacturing process, further QC  inspections (WIP), resulting in the finished product and final QA . The role of risk-management tools such as ISO 14971 and ICH Q9 play in decision making and implementation of CGMP-compliant RM systems. Post-production issues will be also discussed.  The webinar includes a challenges and conclusion session as well.

Learning Objectives:

  • Detailed information to help you gain a better understanding of the requirements regarding the CGMPs and also ISO 13485.
  • How do RM fit into all the quality system elements, why, how controlled and documented
  • Types and content of expected records
  • Details regarding evaluation and selection of suppliers / Purchase Orders / Quality Agreements
  • Risk management-assessment tools and models under ISO 14971 / ICH Q9
  • Metrics you must consider and methods to implement
  • Understand some of the challenge

Areas Covered in the Webinar: 

  • US FDA Regulatory Background
  • Intent of the CGMPs regarding Raw Materials and Risk Management
  • Responsibilities
  • Key Definitions
  • The RM chain and FDA expectations at each key control point
  • What Does 21 CFR Part 210 / 211 and 820 Require
  • Other CGMPs and RM issues
  • Related requirements of EU and  ISO 13485
  • Document Control / Records Requirements
  • FDA Tracking Expectations:  RM and Finished Product
  • “Manufacturing materials”
  • Communication and Change Notification
  • Level of Controls
  • Risk Management/ Assessment per ISO 14971 or ICH Q9
  • Warning Letters and common FDA 483 Observations
  • Challenges

Who Will Benefit:

  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Quality Control Professionals
  • Supply Chain Personnel
  • Hazard Analysis and Risk Management Personnel
  • Complaint Handling Professionals
  • Purchasing Personnel
  • R&D Staff
  • Manufacturing Engineers
  • Process Development Personnel
  • Operations Personnel
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

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